Mimics Automatic Algorithms All Bones CT

GUDID 05404028000342

Mimics Automatic Algorithms All Bones CT

Materialise NV

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software

• Primary Device ID: 05404028000342
• NIH Device Record Key: 165cb468-cbc8-4cd1-ba63-c563b657f4e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mimics Automatic Algorithms
• Version Model Number: All Bones CT
• Catalog Number: All Bones CT
• Company DUNS: 373139427
• Company Name: Materialise NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05404028000342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183105

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-24
• Device Publish Date: 2022-10-15

On-Brand Devices [Mimics Automatic Algorithms]

• 05404028000380: Mimics Automatic Algorithms Hip CT
• 05404028000373: Mimics Automatic Algorithms Shoulder CT
• 05404028000366: Mimics Automatic Algorithms CMF CBCT
• 05404028000342: Mimics Automatic Algorithms All Bones CT
• 05404028000663: Mimics Automatic Algorithms CMF CT